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FDAFDA · Food and drugs·Recall number Z-0271-2014

Siemens syngo.plaza image processing system image processing radiological system

Published November 20, 2013 · Recall initiated: August 8, 2011

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Siemens Medical Solutions USA, Inc
Distributor
Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.
Lot
Model Number 10592457 with serial numbers 100263, 100177, 100138, 100174, 100005, 100006, 100007, 100008, 100009, 100010, 100219, 100201, 100198, 100181, 100249, 100301, 100302, 100157, 100146
Risk classification
Class II
Area (FDA)
device
Country
United States

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